U.S. patent number 7,381,427 [Application Number 10/684,136] was granted by the patent office on 2008-06-03 for seborrheic keratosis treatment.
This patent grant is currently assigned to Mickey Miller. Invention is credited to Margaret Ancira, Mickey Miller.
United States Patent |
7,381,427 |
Ancira , et al. |
June 3, 2008 |
**Please see images for:
( Certificate of Correction ) ** |
Seborrheic keratosis treatment
Abstract
The subject of the present invention is seborrheic keratosis
removal and prevention utilizing safe dependable effective
biocompatible treatments with no scarring, bleeding, burning,
freezing, shocking, and hypopigmentation or hyperpigmentation.
Inventors: |
Ancira; Margaret (Phoenix,
AZ), Miller; Mickey (Paradise Valley, AZ) |
Assignee: |
Miller; Mickey (Paradise
Valley, AZ)
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Family
ID: |
26753799 |
Appl.
No.: |
10/684,136 |
Filed: |
October 9, 2003 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20040137077 A1 |
Jul 15, 2004 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10072829 |
Feb 8, 2002 |
7138146 |
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60267978 |
Feb 9, 2001 |
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Current U.S.
Class: |
424/616; 514/356;
514/276; 514/474; 514/251 |
Current CPC
Class: |
A61K
8/22 (20130101); A61K 8/33 (20130101); A61K
8/676 (20130101); A61K 33/40 (20130101); A61Q
19/00 (20130101); A61K 33/40 (20130101); A61K
2800/28 (20130101); A61K 2300/00 (20130101) |
Current International
Class: |
A61K
33/40 (20060101) |
Field of
Search: |
;424/616
;514/251,276,356,474 |
References Cited
[Referenced By]
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.
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.
Answer and Counter Claim filed Dec. 2, 2003 in Physicians Choice of
Arizona, Inc. v. Mickey Miller, CB-2003-020242 (Superior Court of
Arizona, Maricopa County). cited by other.
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Primary Examiner: Lankford; L Blaine
Attorney, Agent or Firm: Oney; Richard E. Knedlik; Lana
M.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part application of U.S.
patent application Ser. No. 10/072,829 filed on Feb. 8, 2002, now
U.S. Pat. No. 7,138,146 which is a continuation-in-part application
of U.S. Provisional Patent Application Ser. No. 60/267,978, filed
Feb. 9, 2001.
Claims
What is claimed is:
1. A method for treating seborrheic keratoses comprising: (a)
obtaining a composition comprising hydrogen peroxide in a
concentration of at least about 23 percent; and (b) applying said
composition to a seborrheic keratosis on a seborrheic keratoses
afflicted person or domesticated animal.
2. The method of claim 1, wherein the concentration of hydrogen
peroxide is from about 35 percent to about 60 percent.
3. The method of claim 2, wherein the concentration of hydrogen
peroxide is from about 60 percent to about 80 percent.
4. The method of claim 3, wherein the concentration of hydrogen
peroxide is from about 40 percent to about 50 percent.
5. The method of claim 4, wherein the concentration of hydrogen
peroxide is from about 43 percent to about 48 percent.
6. The method of claim 1, wherein the composition further comprises
at least one vitamin.
7. The claim 6, wherein the vitamin may be selected from the group
consisting of ascorbic acid, niacin, thiamin, and riboflavin.
8. The method of claim 7, wherein the vitamin is L-ascorbic
acid.
9. The method of claim 1, wherein the composition further comprises
at least one amino acid.
10. The method of claim 9, wherein the amino acid is selected from
the group consisting of tyrosine, phenylalanine, carnitine,
arginine, glycine, alanine, valine, leucine, isoleucine, serine,
threonine, cysteine, cystine, methionine, asparagine, glutamine,
lysine, 5-hydroxylysine, histidine, tryptophan, proline, omithine,
and carnosine.
11. The method of claim 10, wherein the amino acid is
L-carnitine.
12. The method of claim 1, wherein the composition further
comprises at least one melanin inhibitor.
13. The method of claim 12, wherein the melanin inhibitor is
selected from the group consisting of hydroquinone, niacinimide,
cinnamic acid, gamma-L-glutamyl-L-cystine, gamma-L-cysteine,
oxidized glutathione, phenol, polyphenol, linoleic acid, ellagic
acid, glycyrrhizic acid, alkylsalicylic acid, kojic acid, kojic
acid glycosides, kojic acid succinimide ester, kojic acid dimer,
thiazoles, propionic acid, sulphur, kudzu root, lavanol, caffeic
acid, dicaffeoylquinic acid, tricaffeoylquinic acid, vitamin K,
hydantoin, tranexamic acid, chromone derivative, indomethicin
methacin, erthorbic acid, glucoside, conchiolin hydrolyzate,
licorice root extract, logwood extract, gromwell seed extract,
arbutin, chitosan, superoxide dismutase, melanostatin, S-lactoyl
glutathione, and hydroquinone glycoside.
14. The method of claim 13, wherein the melanin inhibitor is kojic
acid.
15. The method of claim 1, wherein the composition further
comprises at least one organic acid.
16. The method of claim 15, wherein the organic acid is selected
from the group consisting of lactic acid, citric acid, isocitric
acid, glycolic acid, malic acid, tartronic acid, tartaric acid,
glucoronic acid, pyruvic acid, acetyl pyruvic acid,
.beta.-fluoropyruvic acid, 2-hydroxy isobutyric acid, galacturonic
acid, salicylic acid, succinic acid, mandelic acid,
.beta.-phenyllactic acid, saccharic acid, .beta.-phenylpyruvic
acid, .alpha.-hydroxybutyric acid, .alpha.-hydroxyisobutyric acid,
mucic acid, atrolactic acid, glucoheptonic acid, gluconic acid,
glyceric acid, quinic acid, glyceruric acid, threuric acid,
erythreuric acid, xyluric acid, lyxuric acid, arabinuric acid,
riburic acid, iduric acid, guluric acid, mannuric acid, altruric
acid, alluric acid, taluric acid, xylaric acid, lyxaric acid,
trihydroxybutanoic acid, pentahydroxyhexanoic acid, and
hexahydroxyheptanoic acid.
17. The method of claim 16, wherein the organic acid is L-lactic
acid.
18. The method of claim 1, wherein the composition further
comprises at least one hormone.
19. The method of claim 18, wherein the hormone is selected from
the group consisting of dehydroepiandrosterone, progesterone,
estrogen, melatonin, testosterone, pregnenolone, thyroid hormone,
thymus hormone, and human growth hormone.
20. The method of claim 19, wherein the hormone is melatonin.
21. The method of claim 1, wherein the composition further
comprises at least one sulfoxide.
22. The method of claim 21, wherein the sulfoxide is selected from
the group consisting of dimethylsulfoxide and
decylmethylsulfoxide.
23. The method of claim 22, wherein the sulfoxide is
dimethylsulfoxide.
24. The method of claim 1, wherein the composition further
comprises at least one alcohol.
25. The method of claim 24, wherein the alcohol is selected from
the group consisting of ethanol, propanol, butanol, pentanol,
hexanol, octanol, nonanol, decanol, 2-butanol, 2-pentanol, and
benzyl alcohol.
26. The method of claim 25, wherein the alcohol is ethanol.
27. The method of claim 1, wherein the composition comprises at
least one fatty acid.
28. The method of claim 27, wherein the fatty acid is selected from
the group consisting of valeric acid, heptanoic acid, pelagonic
acid, caproic acid, capric acid, lauric acid, myristic acid,
stearic acid, oleic acid and caprylic acid.
29. The method of claim 28, wherein the fatty acid is myristic
acid.
30. The method of claim 1, wherein the composition further
comprises at least one fatty acid ester.
31. The method of claim 30, wherein the fatty acid ester is
selected from the group consisting of isopropyl myristate,
isopropyl palmitate, octyldodecyl myristate, ethyl acetate, butyl
acetate, methyl acetate, methylvalerate, methylpropionate, diethyl
sebacate, ethyl oleate.
32. The method of claim 31, wherein said fatty acid ester is
isopropyl palmitate.
33. The method of claim 1, wherein the applying step is by brush,
dropper, atomizer, injector, sprayer, occlusive patch or
pipette.
34. The method of claim 1, wherein the composition further
comprises at least one polyol.
35. The method of claim 34, wherein the polyol is selected from the
group consisting of propylene glycol, polyethylene glycol, ethylene
glycol, diethylene glycol, triethylene glycol, dipropylene glycol
and glycerol.
36. The method of claim 34, wherein the polyol is propylene
glycol.
37. The method of claim 1, wherein the composition further
comprises at least one amide.
38. The method of claim 37, wherein the amide is selected from the
group consisting of urea, dimethylacetamide, diethyltoluamide,
dimethylformamide, dimethyloctamide, dimethyldecamide,
hexamethylenelauramide, diethanolamine, and triethanolamine.
39. The method of claim 38, wherein the amide is
dimethylformamide.
40. The method of claim 1, wherein the concentration of hydrogen
peroxide is at least 40 percent.
41. The method of claim 1, wherein the composition further
comprises at least one surfactant.
42. The method of claim 41, wherein the surfactant is selected from
the group consisting of sodium laurate, sodium lauryl sulphate,
cetyltrimethyl ammonium bromide, tetradecyltrimethylammonium
bromide, benzalkonium chloride, octadecyltrimethylammonium
chloride, cetylpyridinium chloride, dodecyltrimethylammonium
chloride, hexadecyltrimethylammonium chloride, Poloxamer (231, 182,
184), Brij (30, 93, 96,99), Span (20, 40, 60, 80), Myrj (45, 51,
52), Miglyol 840, sodium cholate, sodium salts of taurocholic,
glycolic, desoxycholic acids and lecithin.
43. The method of claim 42, wherein the surfactant is lecithin.
44. The method of claim 1, wherein the composition further
comprises at least one terpene.
45. The method of claim 44, wherein the terpene is selected from
the group consisting of D-limonene, .alpha.-pinene, .beta.-carene,
.alpha.-terpineol, terpinen-4-ol, carvol, carvone, pulegone,
piperitone, menthone, cyclohexene oxide, limonene oxide,
.alpha.-pinene oxide, cyclopentene oxide, 1,8-cineole, ylang ylang,
anise, chenopodium and eucalyptus.
46. The method of claim 45, wherein the terpene is cyclohexene
oxide.
47. The method of claim 1, wherein the composition further
comprises at least one alkanone.
48. The method of claim 47, wherein the alkanone is selected from
the group consisting of N-heptane, N-octane, N-nonane, N-decane,
N-undecane, N-dodecane, N-tridecane, N-tetradecane, and
N-hexadecane.
49. The method of claim 48, wherein the alkanone is N-octane.
50. The method of claim 1, wherein the composition further
comprises at least one gamma linolenic precursor.
51. The method of claim 50, wherein the gamma linolenic acid
precursor is selected from the group consisting of borage oil,
black currant oil, and evening primrose oil.
52. A method for the removal of a seborrheic keratosis or
seborrheic keratoses comprising: (a) obtaining a composition
comprising hydrogen peroxide in a concentration of at least 23
percent and at least one compound selected from a vitamin, an amino
acid, a melanin inhibitor, an organic acid, a hormone, a sulfoxide,
an alcohol, a fatty acid, a fatty acid ester, a polyol, an amide, a
surfactant, a terpene, an alkanone, aloe vera, and a gamma
linolenic precursor; and (b) applying said composition to a
seborrheic keratosis or seborrheic keratoses on a seborrheic
keratosis or seborrheic keratoses afflicted person.
53. The method of claim 52, wherein the composition comprises about
26 percent hydrogen peroxide, about 2 percent kojic acid, about 12
percent dimethylsulfoxide, about 0.5 percent melatonin, about 1
percent L-ascorbic acid and about 15 percent ethanol.
54. The method of claim 52, wherein the composition comprises about
47 percent hydrogen peroxide, about 14 percent lactic acid, about 2
percent niacin, about 2 percent testosterone, about 1 percent
licorice root extract, and about 0.5 percent .beta.-phenylpyruvic
acid.
55. The method of claim 52, wherein the composition comprises about
23 percent hydrogen peroxide, about 2 percent L-tyrosine, about 2
percent phenylalanine, about 1 percent tricaffeoylquinic acid, and
about 18 percent ethanol.
56. The method of claim 52, wherein the composition comprises about
35 percent hydrogen peroxide and about 35 percent
dimethylsulfoxide.
57. The method of claim 52, wherein the composition comprises about
35 percent hydrogen peroxide, about 0.5 percent L-ascorbic acid,
about 0.5 percent niacin, about 0.5 percent glycine, about 0.5
percent hydroquinone, about 0.5 percent superoxide dismutase, about
5 percent galacturonic acid and about 14 percent ethanol.
58. The method of claim 52, wherein the composition comprises about
60 percent hydrogen peroxide and about 6 percent
decylmethylsulfoxide.
59. The method of claim 52, wherein the composition comprises kojic
acid, dimethylsulfoxide, melatonin, L-ascorbic acid and
ethanol.
60. The method of claim 52, wherein the composition comprises
hydrogen peroxide, lactic acid, niacin, testosterone, licorice root
extract and .beta.-phenylpyruvic acid.
61. The method of claim 52, wherein the composition comprises
L-tyrosine, phenylalanine, tricaffeoylquinic acid and ethanol.
62. The method of claim 61, wherein the composition comprises about
23 percent hydrogen peroxide, about 2 percent phenylalanine, about
1 percent tricaffeoylquinic acid and about 18 percent ethanol.
63. The method of claim 52, wherein the composition comprises
hydrogen peroxide, lactic acid, salicylic acid, citric acid,
glycolic acid, and ethanol.
64. The method of claim 63, wherein the composition comprises about
23 percent hydrogen peroxide, about 4 percent lactic acid, about 4
percent glycolic acid, about 4 percent salicylic acid, about 4
percent citric acid and about 20 percent ethanol.
65. The method of claim 52, wherein the composition comprises
dimethylsulfoxide.
66. The method of claim 52, wherein the composition comprises
L-ascorbic acid, niacin, glycine, hydroquinone, superoxide
dismutase, galacturonic acid and ethanol.
67. The method of claim 66, wherein the composition comprises about
35 percent hydrogen peroxide, about 0.5 percent L-ascorbic acid,
about 0.5 percent glycine, about 0.5 percent hydroquinone, about
0.5 percent superoxide dismutase, about 5 percent galacturonic acid
and about 14 percent alcohol.
68. The method of claim 52, wherein the composition comprises
decylmethylsulfoxide.
69. The method of claim 68, wherein the composition comprises about
60 percent hydrogen peroxide and about 6 percent
decylmethylsulfoxide.
70. The method of claim 1, wherein the composition further
comprises aloe vera.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention provides topical compositions and methods for
the treatment, removal, elimination and prevention of seborrheic
keratoses. More specifically, the present invention involves the
use of high concentration hydrogen peroxide to treat the
affliction.
2. Description of Related Art
Seborrheic keratoses are the most common benign lesions observed in
humans. According to the U.S. National Health and Nutrition
Examination Survey of 1995 1996, about 45 million persons in the
United States have seborrheic keratoses with the distribution being
about equal between the sexes. Seborrheic keratoses were described
as early as 1864 by Virchow and in 1869 by Neumann, who called them
senile warts. Seborrheic keratoses have also been described as
senile verruca, pigmented verruca, keratosis pigmentosa, basal cell
papilloma and a long list of other names in the medical
literature.
Seborrheic keratoses may take a variety of forms, including but not
limited to: dermatosis papulosa nigra, stucco, acanthotic,
hyperkeratotic, dermatolipoma, verrucous, melanoacanthotic,
reticular, adenoid, and clonal.
In general, seborrheic keratoses begin as small, round or oval,
brownish macules. The sites of predilection are the face, scalp,
trunk, particularly the interscapular and sternal regions and the
backs of the hands. In rare cases, seborrheic keratoses have also
been reported in the ear canal and the penis. Seborrheic keratoses
do not occur on the palms of the hands or soles of the feet.
All lesions of seborrheic keratosis, whether small or large, show a
sharp line of demarcation between the pathologic changes seen in
the tumor and the normal adjacent skin.
In a small seborrheic keratosis, the epidermis at the border shows
an abrupt elevation to produce many finger-like upward projections,
each of which contains a central core of connective tissue. These
digitations are covered by a loose non-nucleated scale which dips
down to fill all of the intervening crevices and which forms a
thick plug in each of the follicles.
As the keratosis grows larger the digitations elongate and they
show an irregular cellular hyperplasia to produce anastomoses in
many directions. This acanthosis results in the production of
filiform branches and large epidermal masses and many intervening
passages which are filled by extensions from the surface scale. In
most cases, the granular layer is intact and there are no nuclei in
the scale, but occasionally there are a few islands of
parakeratosis. The basal layer is unbroken and the entire tumor
lies superficial to a base that is level with that of the adjacent
normal skin.
Seborrheic keratoses may grow to become quite large as illustrated
by the report of the giant pedunculated seborrheic keratosis by Dr.
Rudolf L. Baer. The patient was reported at the Department of
Dermatology at the New York University School of Medicine, in the
May 1979 issue of the Archives of Dermatology. The brown-ish lesion
developed on the right inguinal region of a 75 year old woman and
was allowed to grow for 40 years because of the lack of a
convenient treatment such as the present invention for seborrheic
keratosis elimination. The seborrheic keratosis, over a period of
many years, gradually became larger, and eventually formed a
pendulous mass measuring 5.5.times.3.5 centimeters. Due to the lack
of an effective topical treatment such as the present invention,
Dr. Baer had to remove the seborrheic keratosis with a scalpel
while the patient was under local anesthesia with lidocaine and
stop the bleeding by electrodesiccation. Microscopic examination of
the gargantuan seborrheic keratosis revealed epidermal hyperplasia
with horn pseudocysts, interweaving of the rete, and nuclei of
uniform size and shape.
If left untreated, as the vast majority of seborrheic keratoses
are, squamous cell carcinoma may arise as reported by Dr. Rudolf L.
Baer in the November 1981 issue of the Journal of the American
Academy of Dermatology. For some years, due to the lack of an
effective self-applied treatment, a 73-year-old patient had allowed
a seborrheic keratosis to grow on the left side of his trunk. Some
months before consulting Dr. Baer, part of the growth fell off and
then recurred with distinctly more elevation than the remainder of
the seborrheic keratosis. The seborrheic keratosis was described as
a verrucous, keratotic, gray-brown-black, sharply defined lesion
with somewhat scalloped edges. The seborrheic keratosis measured
60.times.27 millimeters and was elevated about 3 mm above the
surrounding normal skin. Two different components were within the
seborrheic keratosis, one somewhat lighter and less elevated,
slightly verrucous area and the second a lighter gray-brown
19.times.18 millimeter cauliflower-like area, elevated 9
millimeters above the surrounding normal skin. Treatment with the
present invention would have prevented the emergence of the
squamous cell carcinoma and eliminated the necessity of the lesion
being excised with a surrounding margin of normal skin.
Multiple seborrheic keratosis treatment is not readily accomplished
by techniques available in conventional practice; therefore, many
people suffering with large numbers of seborrheic keratoses go many
years with no treatment. Such is the case reported by Dr. Robert W.
Cashmore and Dr. Harold O. Perry in the July, 1985 issue of
Geriatrics. A 55-year-old Caucasian man had many, many darkly
pigmented seborrheic keratoses on his trunk for twenty years.
During the twenty years, he was seen for various medical problems,
including and anxiety-tension state and preoccupation with bodily
functions. During this period, he was seen eight times by a
dermatologist for reassurance to alleviate his concern about the
multiple seborrheic keratoses. At his last visit, a 1.times.2
centimeter erythematous lesion was noted among the numerous
keratoses on his right shoulder, and this was thought clinically to
be a superficial basal cell carcinoma. This impression was
confirmed by biopsy. The fact that the man was untreated for twenty
years after being examined eight times by a dermatologist and then
allowed to develop cancer clearly points to the urgent need for an
effective, practical treatment such as the present invention.
Early medical treatment modalities of seborrheic keratoses do not
differ appreciably from the treatment choices offered by the
majority of present day, medical practitioners with the exception
of laser usage for seborrheic keratosis removal, which also results
in adverse side effects such as scarring, hyperpigmentation and
hypopigmentation.
The Jan. 30, 1915 issue of The Journal of the American Medical
Association includes a report titled "The Symptomatology and
Treatment of Seborrheic Keratoses" by the prominent Kansas City,
Mo. physician Richard L. Sutton. A form of cryogenic therapy is
described by Dr. Sutton using Pusey's carbon dioxide snow and a 5
percent ammoniated mercurial ointment. For seborrheic keratoses
that have become malignant, Dr. Sutton recommends radical excision.
Radium and Roentgen rays are the treatment of choice on the face in
the nasal and orbital regions. If Dr. Sutton would have had access
to the present invention, his toxic methods utilizing mercury would
not have been necessary.
High-frequency electrosurgery has provided dermatology and other
areas of medicine with an efficient means of tissue destruction and
hemostatis which has been used for seborrheic keratosis removal.
When electrosurgery is used for seborrheic keratosis removal,
little attention is given to risks of contamination. Indirect
contamination can occur as a result of the aerosolization of blood
droplets secondary to mechanical actions at the high-frequency
electrosurgery site. Hepatitis B or human immunodeficiency disease
might be spread through aerosolized microdroplets of blood and
electrosurgical smoke.
Electrocoagulation incorporates the patient himself into the
electrical circuit with the use of a dispersive electrode plate.
This dispersive electrode plate allows the machine to deliver a
larger amount of current to the patient. Electrocoagulation occurs
when electrosurgical current is applied to the tissue with
resistance (ohmic) heat production that cooks tissue. The cooked
tissue produces aerosolized microdroplets of blood and
electrosurgical smoke. The mechanical action of electrosurgical
current entering tissue can give rise to very small blood droplets
that can travel a great distance. These droplets get scattered all
about the surgical field. Of further concern is the problem of the
microdroplets that cannot be seen but may be inhaled or received
through the conjunctival surfaces.
Electrodesiccation is the superficial dehydration of tissue as a
result of the passage of high-frequency current which leads to
scarring and hypopigmentation in some treatments of seborrheic
keratosis removal.
Every medical practitioner and dermatologist who practices
high-frequency electrosurgery should provide surgical masks and eye
protection to everyone in the premises and sterilize all exposed
surfaces.
The smoke generated by laser surgery is capable of carrying viable
viral particles. Seborrheic keratosis elimination attempts with
various lasers commonly used in dermatology such as the carbon
dioxide, erbium:YAG, and ND:YAG have been so disappointing that the
treatment often leaves a worse cosmetic result than the seborrheic
keratosis consisted of.
Cryosurgery of seborrheic keratoses with liquid nitrogen and carbon
dioxide has been found to cause dischromic patches due to freezing
of the skin surrounding the margin of the lesion. Recovery of the
patient takes up to three weeks versus no recovery time using the
present invention.
Seborrheic keratoses are the leading cause of visits to
dermatologists according to Henry H. Roenigk, Jr. M. D., a leading
dermatologist with the Mayo Clinic in Scottsdale, Ariz. Dr. Roenigk
generally discourages seborrheic keratosis treatment of any type
unless trauma or malignancy of the seborrheic keratosis is
present.
Medical practitioners such as dermatologists, plastic surgeons and
general practitioners are extremely reluctant to treat facial
seborrheic keratoses with current methods because of the high
incidence of lawsuits due to unsatisfactory results such as
scarring, hyperpigmentation and hypopigmentation.
Twenty five dermatologists and medical doctors in metropolitan
practice were surveyed as to seborrheic keratosis removal method,
side effects, pricing, insurance reimbursement, and appointment
lead time. Fifty-two percent of the dermatologists surveyed used
the inject, cut, burn, and bandage method of seborrheic keratosis
removal with no form of seborrheic keratosis prevention. All of the
dermatologists and medical doctors surveyed reported scarring after
their particular type of treatment. None of the dermatologists or
medical doctors surveyed reported using any type of topical
treatment, clearly pointing to the need for the present invention
of seborrheic keratosis elimination.
SUMMARY OF THE INVENTION
The present invention overcomes the drawbacks in the art by
providing improved treatments for the safe, effective treatment,
elimination, and prevention of seborrheic keratoses anywhere on the
patient, including but not limited to the eyelids, groin and
axillae.
In another aspect of the present invention, a seborrheic keratosis
treatment composition is provided which can be applied by a
dermatologist, physician, plastic surgeon, medical ancillary
personnel, and an aesthetician, as well as by the patient using
at-home products. It may be applied using any suitable means, such
as by brush, dropper, atomizer, injector, sprayer, occlusive patch
or pipette.
In accordance with the present invention, various reactive oxygen
species and oxidative compositions are employed to elicit
necrogenous oxidation and oxygen induced apoptosis of cells in the
seborrheic keratoses with oxygenation normalization of adjacent
cells.
In accordance with the present invention, a seborrheic keratosis
composition is provided which can be used to treat any type and
location of the specific seborrheic keratosis.
In one aspect of the invention, the seborrheic keratosis treatment
compositions are comprised of reactive oxygen species, such as the
hydrogen peroxide, superoxide anion, and hydroxyl radicals. In
particular, hydrogen peroxide in a concentration far above levels
encountered in mammalian metabolism is applied until the offending
seborrheic keratosis is eliminated from the skin.
In another aspect of the invention, a method is provided for the
treatment of seborrheic keratosis comprising: (a) obtaining a
composition comprising hydrogen peroxide in a concentration of at
least 23 percent; (b) and applying said composition to an
acrochordon on an seborrheic keratosis afflicted person or animal,
including domesticated animals. In certain embodiments of the
invention, a concentration of hydrogen peroxide used may be least
23, 24, 27, 30, 35, 40, 43, 48, 50, 55, 60, 65, 70, 75 or at least
80 percent and may also be from about 23 percent to about 80
percent; from about 35 percent to about 60 percent; from about 35
percent to about 40 percent, from about 40 percent to about 50
percent, from about 43 percent to about 48 percent, and from about
60 to about 80 percent.
The composition may also include various organic solvents, amino
acids, vitamins, organic and/or inorganic minerals; alpha hydroxy,
beta hydroxy, carboxylic or keto acids, hormones, enzymes,
coenzymes, botanical actives and/or organic oxides and
reductants.
In another aspect of the invention, a composition used in
accordance with the methods of the invention may comprise
ingredients in addition to hydrogen peroxide, for example, at least
one vitamin. In one embodiment of the invention, the vitamin is
selected from the group consisting of ascorbic acid, niacin,
thiamin and riboflavin and may also be L-ascorbic acid.
In another aspect of the present invention, the composition may
also comprise at least one amino acid, including, for example,
tyrosine, phenylalanine, carnitine, arginine, glycine, alanine,
valine, leucine, isoleucine, serine, threonine, cysteine, cystine,
methionine, asparagine, glutamine, lysine, 5-hydroxylysine,
histidine, tryptophan, proline, omithine, and carnosine. In one
embodiment of the invention, the amino acid is L-carnitine.
In another aspect of the invention, a composition used in
accordance with the methods of the invention may comprise at least
one melanin inhibitor. Examples of such melanin inhibitors include
hydroquinone, niacinimide, cinnamic acid,
gamma-L-glutamyl-L-cystine, gamma-L-cysteine, oxidized glutathione,
phenol, polyphenol, linoleic acid, ellagic acid, glycyrrhizic acid,
alkylsalicylic acid, kojic acid, kojic acid glycosides, kojic acid
succinimide ester, kojic acid dimer, thiazoles, propionic acid,
sulphur, kudzu root, lavanol, caffeic acid, dicaffeoylquinic acid,
tricaffeoylquinic acid, vitamin K, hydantoin, tranexamic acid,
chromone derivative, indomethicin methacin, erthorbic acid,
glucoside, conchiolin hydrolyzate, licorice root extract, logwood
extract, gromwell seed extract, arbutin, chitosan, superoxide
dismutase, melanostatin, S-lactoyl glutathione, and hydroquinone
glycoside. Other melanin inhibitors include azelaic acid, bearberry
extract, bilberry extract, rumex crispus, magnesium ascorbyl
phosphate, ascorbyl palmitate, phytic acid, and niacinamide. In one
embodiment of the invention the melanin inhibitor is kojic
acid.
In still yet another aspect of the invention, a composition used in
accordance with the methods of the invention may comprise at least
one organic acid. Examples of such an organic acid include lactic
acid, citric acid, isocitric acid, glycolic acid, malic acid,
tartronic acid, tartaric acid, glucoronic acid, pyruvic acid,
acetyl pyruvic acid, .beta.-fluoropyruvic acid, 2-hydroxy
isobutyric acid, galacturonic acid, salicylic acid, succinic acid,
mandelic acid, .beta.-phenyllactic acid, saccharic acid,
.beta.-phenylpyruvic acid, .alpha.-hydroxybutyric acid,
.alpha.-hydroxyisobutyric acid, mucic acid, atrolactic acid,
glucoheptonic acid, gluconic acid, glyceric acid, quinic acid,
glyceruric acid, threuric acid, erythreuric acid, xyluric acid,
lyxuric acid, arabinuric acid, riburic acid, iduric acid, guluric
acid, mannuric acid, altruric acid, alluric acid, taluric acid,
xylaric acid, lyxaric acid, trihydroxybutanoic acid,
pentahydroxyhexanoic acid, hexahydroxyheptanoic acid, and phytic
acid. In one embodiment of the invention, the organic acid is
L-lactic acid.
In still yet another aspect of the invention, a composition used in
accordance with the methods of the invention may comprise at least
one hormone. Examples of such hormones include
dehydroepiandrosterone, progesterone, estrogen, melatonin,
testosterone, pregnenolone, thyroid hormone, thymus hormone, human
growth hormone and melatonin. In one embodiment, the hormone is
melatonin.
A composition used with the invention may also comprise at least
one sulfoxide. Examples of such a sulfoxide include is selected
from the group consisting of dimethylsulfoxide and
decylmethylsulfoxide. In one embodiment of the invention, the
sulfoxide is dimethylsulfoxide.
In still yet another aspect of the invention, a composition used in
accordance with the methods of the invention may comprise at least
one alcohol, including ethanol, propanol, butanol, pentanol,
hexanol, octanol, nonanol, decanol, 2-butanol, 2-pentanol, benzyl
alcohol and ethanol. In one embodiment, the alcohol comprises
ethanol.
In still another aspect of the present invention, the composition
may also comprise at least one fatty acid, including valeric acid,
heptanoic acid, pelagonic acid, caproic acid, capric acid, lauric
acid, myristic acid, stearic acid, oleic acid, caprylic acid and
myristic acid. In one embodiment, the fatty acid comprises myristic
acid.
In another aspect of the present invention, the composition may
still further comprise at least one fatty acid ester, including
isopropyl myristate, isopropyl palmitate, octyldodecyl myristate,
ethyl acetate, butyl acetate, methyl acetate, methylvalerate,
methylpropionate, diethyl sebacate, and ethyl oleate. In one
embodiment, the fatty acid ester is isopropyl palmitate.
In another aspect of the present invention, the composition may
also comprise at least one polyol, including propylene glycol,
polyethylene glycol, ethylene glycol, diethylene glycol,
triethylene glycol, dipropylene glycol, glycerol and propylene
glycol. In one embodiment, the composition comprises propylene
glycol.
In accordance with the present invention, the composition may also
comprise at least one amide, including urea, dimethylacetamide,
diethyltoluamide, dimethylformamide, dimethyloctamide,
dimethyldecamide, hexamethylenelauramide, diethanolamine,
triethanolamine and dimethylformamide. In one embodiment, the amide
is dimethylformamide.
In still yet another aspect of the invention, a composition used in
accordance with the invention may comprises at least one
surfactant, including sodium laurate, sodium lauryl sulphate,
cetyltrimethyl ammonium bromide, tetradecyltrimethylammonium
bromide, benzalkonium chloride, octadecyltrimethylammonium
chloride, cetylpyridinium chloride, dodecyltrimethylammonium
chloride, hexadecyltrimethylammonium chloride, Poloxamer (231, 182,
184), Brij (30, 93, 96,99), Span (20, 40, 60, 80), Myrj (45, 51,
52), Miglyol 840, sodium cholate, sodium salts of taurocholic,
glycolic, desoxycholic acids and lecithin. In one embodiment, the
surfactant is lecithin.
In still yet another aspect of the present invention, the
composition may also comprise at least one terpene, including
D-limonene, .alpha.-pinene, .beta.-carene, .alpha.-terpineol,
terpinen-4-ol, carvol, carvone, pulegone, piperitone, menthone,
cyclohexene oxide, limonene oxide, .alpha.-pinene oxide,
cyclopentene oxide, 1,8-cineole, ylang ylang, anise, chenopodium
and eucalyptus. In one embodiment, the terpene is cyclhexene
oxide.
In another aspect of the present invention, the composition may
also comprise at least one alkanone, including N-heptane, N-octane,
N-nonane, N-decane, N-undecane, N-dodecane, N-tridecane,
N-tetradecane, and N-hexadecane. In one embodiment, the alkanone is
N-octane.
In another aspect of the present invention, the composition may
still further comprise aloe vera.
In still yet another aspect of the invention, a composition used in
accordance with the invention may comprise at least one gamma
linoleic precursor, including borage oil, black currant oil, and
evening primrose oil.
In still yet another aspect, the invention provides a method for
the removal of seborrheic keratosis comprising: (a) obtaining a
composition comprising hydrogen peroxide in a concentration of at
least 23 percent and at least one compound selected from the group
consisting of a vitamin, an amino acid, a melanin inhibitor, an
organic acid, a hormone, a sulfoxide, an alcohol, a fatty acid, a
fatty acid ester, a polyol, an amide, a surfactant, a terpene, an
alkanone, aloe vera, and a gamma linoleic precursor; and (b)
applying said composition to an acrochordon on an seborrheic
keratosis afflicted person or domesticated animal.
In certain embodiments of the invention, the concentration of
hydrogen peroxide is at least about 23, 24, 27, 30, 35, 40, 43, 48,
50, 55, 60, 65, 70, 75 or at least about 80%, including from about
23 percent to about 60 percent, from about 35 percent to about 60
percent, from about 35 percent to about 40 percent, from about 40
percent to about 50 percent, and from about 43 percent to about 48
percent.
In one embodiment, the composition may additionally comprise kojic
acid, dimethylsulfoxide, melatonin, L-ascorbic acid and ethanol;
including about at least 26 percent hydrogen peroxide. More
particularly, in one embodiment, the composition comprises about 1
5 percent kojic acid, about 10 15 percent dimethylsulfoxide, about
0.1 to 1 percent melatonin, 0.5 to 2 percent L-ascorbic acid and 10
20 percent ethanol.
In another embodiment of the invention, the composition may
additionally comprise lactic acid, niacin, testosterone, licorice
root extract, and -phenylpyruvic acid. For example, the composition
may contain about 47 percent hydrogen peroxide, about 14 percent
lactic acid, about 2 percent niacin, about 2 percent testosterone,
about 1 percent licorice root extract, and about 0.5 percent
.beta.-phenylpyruvic acid. In yet another embodiment of the
invention, the composition may additionally comprise L-tyrosine,
phenylalanine, tricaffeoylquinic acid and ethanol; including a
composition of about 23 percent hydrogen peroxide, about 2 percent
L-tyrosine, about 2 percent phenylalanine, about 1 percent
tricaffeoylquinic acid, and about 18 percent ethanol.
In the method, the composition may comprise lactic acid, glycolic
acid, salicylic acid, citric acid, and ethanol. For example, the
invention includes a composition of about 23 percent hydrogen
peroxide, about 4 percent lactic acid, about 4 percent glycolic
acid, about 4 percent salicylic acid, about 4 percent citric acid,
and about 20 percent ethanol. The composition may also comprise
dimethysulfoxide; including a composition of about 35 percent
hydrogen peroxide and about 35 percent dimethysulfoxide. The
composition may still further comprise L-ascorbic acid, niacin,
glycine, hydroquinone, superoxide dismutase, galacturonic acid and
ethanol; including a composition of about 35 percent hydrogen
peroxide, about 0.5 percent L-ascorbic acid, about 0.5 percent
niacin, about 0.5 percent glycine, about 0.5 percent hydroquinone,
about 0.5 percent superoxide dismutase, about 5 percent
galacturonic acid and about 14 percent ethanol. In another
embodiment of the invention, the composition may additionally
comprise decylmethylsulfoxide; including a composition of about 60
percent hydrogen peroxide and 6 percent decylmethylsulfoxide.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a photograph showing a patient having seborrheic
keratosis before treatment in accordance with the present
invention.
FIG. 2 is a photograph showing the patient of FIG. 1 after
undergoing treatment in accordance with the present invention.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
The present invention provides effective methods for removal and
prevention of unsightly and potentially precancerous seborrheic
keratoses while avoiding the pain and scarring that accompanies
presently known techniques. The inventors have discovered that
reactive oxygen species such as the superoxide radical, hydrogen
peroxide, hydroxyl radical, singlet oxygen and ozone, as well as
other oxidants, are effective in eliminating seborrheic keratoses
when applied in sufficient concentration and frequency. The
preferred active agents include hydrogen peroxide, benzoyl
peroxide, and alloyl peroxide.
One such method of oxidative seborrheic keratosis elimination is
providing one or more applications of a composition including
unstabilized hydrogen peroxide with a concentration of at least 23
percent. High concentration food grade hydrogen peroxide
application results in, surprisingly, the complete removal of
seborrheic keratoses, and other unsightly and undesirable skin
disorders, without causing scarring, hypopigmentation or
hyperpigmentation.
Removal and prevention treatments of the present invention may
include components with a high degree of bio-compatibility, such as
products of mammalian metabolism, components of the electron
transport chain and may include hydrogen peroxide, amino acids,
vitamins, organic and/or inorganic minerals; alpha hydroxy, beta
hydroxy, carboxylic or keto acids, hormones, enzymes, coenzymes and
various penetration enhancers. Other components such as botanical
actives and/or organic oxides and reductants may also be employed,
as is known to those of skill in the art. Such compounds may be
contained in a solvent such as water or another solvent compatible
with hydrogen peroxide. Further, physiologically acceptable
adjuvants may also be chosen, for example, pH-regulating agents,
antioxidants, preservatives, pigments and colorings, emollients,
antifoams, plant or animal oils or waxes, silicones, perfumes,
surfactants, plasticizers, thickening polymers other compounds. Of
course, persons skilled in the art will be careful to choose any
such optional additional compounds and their quantity so that the
active properties of the hydrogen peroxide are not substantially
reduced by the addition.
One preferred brand of hydrogen peroxide found to function well is
Durox.TM., manufactured in the Hydrogen Peroxide Division of FMC of
Canada Ltd. The methods of the invention involve a sufficient
topical application of the oxidative composition directly to the
selected seborrheic keratosis. The oxidative composition may be
left on the treated seborrheic keratosis without removal and
additional applications applied during a treatment.
Another preferred embodiment of the present invention designed for
the rapid oxidative elimination of seborrheic keratoses comprises
unstabilized 35 percent hydrogen peroxide and ferrous sulphate such
as product number F 7002 produced by the Sigma-Aldrich Company of
St. Louis, Mo. The inclusion of ferrous sulphate in the oxidative
composition produces the highly reactive hydroxyl radical by the
Fenton reaction. The Fenton reaction is
H.sub.2O.sub.2+Fe.sup.2+.fwdarw.OH.+OH.sup.-+Fe.sup.3+. The
hydroxyl radical is the most reactive oxygen radical known to
biochemistry. The hydroxyl radicals initiate free radical chain
reactions, which produce lipid peroxidation and lysis in the cells
of the seborrheic keratoses. Titanium, copper, cobalt and chromium
salts in combination with high concentration food grade hydrogen
peroxide may also be utilized in hydroxyl radical generating
compositions for the destruction of undesirable cutaneous
lesions.
Some patients may experience a slight to moderate burning or
stinging sensation upon the application of the oxidative
composition, particularly when higher concentrations of 35 percent
or greater of unstabilized hydrogen peroxide are used. While the
composition may be left on without further treatment even when a
transient burning or stinging sensation occurs, it may be desirable
to further treat the affected area with a neutralizing composition,
such as distilled water or a lotion or cream such as pHaze 17
ReBalance.TM. cream (Physician's Choice of Arizona).
For total removal of the seborrheic keratosis to occur, more than
one application of the oxidative composition or compositions to the
seborrheic keratosis will sometimes be necessary. It is envisioned
that some seborrheic keratoses may be removed upon one application
with a composition including unstabilized food grade hydrogen
peroxide at higher concentrations, such as about 36 to 55 percent.
However, total removal of the seborrheic keratoses, which may be
treated with the present methods, will in some cases require
several applications of the oxidative compositions described herein
over a period of time. The oxidative composition applications may
be spaced minutes, hours or days apart. It is preferred that
subsequent oxidative composition treatments occur within two or
three days of the previous treatment, although they may be as much
as a week or two apart. The spacing of the oxidative composition
treatments will depend upon such factors as patient sensitivity and
type or types of the seborrheic keratoses present on the seborrheic
keratosis afflicted individual.
While described in terms of seborrheic keratosis removal, the
present invention is also effective in removing other skin
conditions such as condyloma accuminatum, corns, fibroepithelial
polyps, prurigo nodularis, inverted follicular keratosis, warts,
warty dyskeratosis, actinic keratoses, acrochordons, herpes, clear
cell acanthoma, acne, rosacea, basal cell carcinoma, squamous cell
carcinoma, onychomycosis, hyperpigmentation, rhytides, psoriasis
and malignant melanoma.
While the method of the invention is surprisingly and unexpectedly
effective using a composition including simply hydrogen peroxide at
concentrations above about 23 percent, including at least about 23,
24, 27, 30, 35, 40, 43, 48, 50, 55, 60, 65, 70, 75 or at least 80
percent. As used herein, "percent" means percent by weight (w/w).
The compositions for use in the present methods may also include
other substances to aid in penetration, to enhance skin lightening,
to aid in moisturizing or conditioning the skin, as will be known
to those of skill in the art in view of the instant disclosure. For
example, other ingredients may be added to improve the skin
condition or the effectiveness of the compositions. Vitamins may
added to the compositions to aid in improving the skin condition
thereby inhibiting the production of subsequent cutaneous anomalies
after treatment of the original condition
Case histories of patients who have had various types of lesions
successfully removed using the methods of the invention are
provided below. These case histories and the examples that follow
are included simply for illustration of the effectiveness of the
invention and are not meant to limit the scope of the invention in
any way.
Case Histories
Case History Number 1
A forty-five year old Caucasian male marathoner with an irritated
seborrheic keratosis on the iliotibial band near the left knee did
not want to undergo conventional destructive seborrheic keratosis
removal methods and suffer downtime during the marathon season. Nor
did the marathoner want the scarring and hyperpigmentation or
hypopigmentation that results from conventional techniques. The
present invention was applied drop by drop to the irritated
seborrheic keratosis for five consecutive days. The seborrheic
keratosis was dark brown with a hard, shiny surface that resisted
composition penetration on the first four applications. A drop of
the 35 percent hydrogen peroxide seborrheic keratosis composition
was allowed to stand on the lesion for approximately 2 minutes on
each of the first four applications. On the fifth application of
the seborrheic keratosis composition to the offending lesion a
vigorous bubbling reaction occurred as the composition penetrated
the dense previously non-porous surface of the seborrheic
keratosis. The marathoner reported no pain during the treatment
reaction, only a sensation of effervescence. The following day, the
seborrheic keratosis fell off during the marathoner's pre-training
run shower, leaving a very slightly pinkish tone to the healthy
underlying skin. The seborrheic keratosis has not returned three
years post treatment.
Case History Number 2
A thirty-eight year old single mother of two presented with an
unsightly grayish-pink, verrucous seborrheic keratosis covering her
right cheek. She was extremely self-conscious of the lesion and
kept her long hair over the seborrheic keratosis to conceal it. The
lesion was of several years duration and she always declined to
have her picture taken with her family during Christmas and other
holidays. The subject was one of twelve children. Several of her
siblings also carried the seborrheic keratoses although hers was
the worst with the exception of one brother with a large dark
seborrheic keratosis on his forehead. One of her other brothers had
several seborrheic keratoses removed by laser with great expense
and poor results. The dermatologists she consulted recommended
either surgical or laser removal but could not guarantee scar-free
results. The seborrheic keratosis was treated with a 35 percent
plus hydrogen peroxide seborrheic keratosis composition of the
present invention and allowed to react completely. Four days post
treatment, the subject awoke to find the seborrheic keratosis lying
on her pillow. She placed the seborrheic keratosis in a
ZIP-LOCK.RTM. plastic bag and delivered it to the PCA Skin
Center.RTM. where it was sent off for histologic examination. The
subject was overjoyed with the result of her treatment that left no
sign of the seborrheic keratosis. The subject is still keratosis
free three years post treatment.
Case History Number 3
An unemployed 36-year-old Caucasian male musician on disability
with a history of severe depression and disassociative psychosis
presented with a stucco type dark brown seborrheic keratosis of
long duration on the right side of his forehead. He also carried
smaller seborrheic keratoses scattered about his face, chest and
legs. Several acrochordons were present on both sides of neck. The
large seborrheic keratosis measured 2.5.times.3 centimeters in
diameter and was raised about 2.5 millimeters.
The pretreatment interview revealed the man was heavily medicated
daily with eleven prescriptions drugs for control of his mental
condition and depression. His diet consisted of a favorite brand of
TV dinner with continuous coffee consumption and cigarette chain
smoking. He admitted to performing no daily exercise
whatsoever.
Out of twelve children in his family, the majority had at least one
seborrheic keratosis of some type with several family members
afflicted with multiple seborrheic keratoses. He was referred for
treatment by his older sister who had a large disfiguring
seborrheic keratosis on her right cheek, which had been
successfully treated with the present invention. He had been
discouraged from treatment with conventional methods of seborrheic
keratosis treatment by the results obtained from other family
members who had experienced pain, scarring, hyperpigmentation and
great expense. His brother, a prominent Hollywood movie director,
had laser removal of facial seborrheic keratoses at a cost of
several thousand dollars. The laser treatment resulted in facial
scarring and hyperpigmentation with a great deal of discomfort both
during the procedure and post treatment.
Extensive photographic documentation was performed pre and post
treatment to chart treatment progress. The seborrheic keratosis
removal composition of high concentration peroxide of hydrogen was
applied to the seborrheic keratoses and allowed to react completely
with little or no discomfort. The acrochordons present on both
sides of the neck were treated with the hydrogen peroxide
acrochordon composition.
The second seborrheic keratosis treatment was performed one week
later. Several of the smaller seborrheic keratoses had avulsed and
the remainder appeared soon to avulse. The large seborrheic
keratosis on the forehead exhibited detachment around the outer
margin of the lesion.
The acrochordons on the neck had depedunculated and the smaller
facial seborrheic keratoses had fallen off at the time of the third
treatment with no scarring or pigmentation anomalies. The large
forehead seborrheic keratosis showed further signs of detachment.
The seborrheic keratoses typically develop an oxidized scale which
flakes or comes off in various size fragments.
Two days prior to the fourth seborrheic keratosis treatment, the
large 2.5.times.3 centimeter seborrheic keratosis on the forehead
fell off while the subject was taking a shower. A slight seborrheic
keratosis remnant and very slight darker pigmentation were visible
upon close examination. The musician was very pleased with the
results of the treatment.
Further appointments were scheduled to apply the seborrheic
keratosis prevention composition to eliminate newly forming
seborrheic keratoses. Superficial skin peels of the modified
Jessner's type were performed at later dates to freshen the skin
and even out the skin tone where the seborrheic keratoses were
removed.
Follow up visits at three and six months, revealed a dramatically
improved overall facial skin appearance with no visible evidence of
the prior seborrheic keratoses. The subject exhibited a marked
improvement in self-image to correspond with his improved facial
skin appearance. The musician has since returned to performing
music without embarrassment of being on stage because of the
disfiguring seborrheic keratoses.
Case History Number 4
A forty-eight year old Caucasian woman of English and French
descent presented with multiple brownish scaly seborrheic keratoses
of the verrucous type scattered across her entire back. The
seborrheic keratoses varied in size to a maximum of 2.7
centimeters. In contrast to the stucco type keratoses, the lesions
were subsurface to the epidermis as if they were eroding away the
skin.
The subject had a history of heavy consistent antibiotic use and
multiple allergies before a recent conversion to natural medicine.
Her seborrheic keratoses growth began after a severe antibiotic
reaction, which required hospitalization.
A thirty-five percent hydrogen peroxide seborrheic keratosis
treatment composition was applied to the lesions after the border
of the seborrheic keratoses had been surrounded by the protective
pHaze 17 ReBalance.TM. cream to contain the solution within the
area of the lesions.
Lesion blanching was observed after an average of 48 seconds, on
the majority of the larger seborrheic keratoses and the subject
reported a moderate stinging sensation for several minutes. The
majority of the smaller seborrheic keratoses disappeared after the
initial treatment and the larger seborrheic keratoses required 3 to
4 treatments at roughly one-week intervals to obtain complete
resolution.
Case History Number 5
A one centimeter diameter verrucous, pseudohorncystic seborrheic
keratosis on the left jaw anterior to the ear lobe prompted the 53
year old Caucasian female to seek treatment with the current
invention. Her family physician had referred her to a dermatologist
who informed her surgical or laser removal would result in
scarring.
Initial application of the seborrheic keratosis removal composition
caused the irritated seborrheic keratosis to fall off prior to the
second treatment. The very slight remainder of the irritated
seborrheic keratosis was treated to achieve complete resolution
with no scarring, bleeding or pigmentation anomalies.
Seborrheic Keratosis Study Results
Thirty-two subjects afflicted with various types of seborrheic
keratoses, acrochordons and other benign epidermal proliferations
were recruited, screened and enrolled in a one year study to test
the effects of the present invention. The Human Welfare Committee
at Arizona State University in Tempe, Ariz. granted Institutional
Review Board approval to conduct a double blind vehicle controlled
study of the effect of the present invention with active ingredient
versus its vehicle only in the treatment of benign epidermal
proliferations: seborrheic keratoses, benign keratoses, verruca and
others at one year. More than ample study participant candidates
were obtained by one small ad in a small local newspaper. In most
instances, it was almost impossible to tell where the seborrheic
keratoses had been after treatment was completed. On a few
subjects, especially those with darkly pigmented seborrheic
keratoses and fair skin, a faint pinkish coloration remained after
treatment that appears to be fading over time. The procedure was
well tolerated by all subjects except two who displayed unusual
sensitivity and requested premature application of the neutralizing
composition. Most of the seborrheic keratosis carriers treated have
shown no sign of seborrheic keratosis re-growth.
More specifically, a total of 32 patients were initially enrolled
in this study. These were comprised of 12 men and 20 women, having
an average age of 53. During the study, 10 patients were lost to
follow-up. Three patient failed to return after their initial
visit, and were lost to follow-up, despite multiple attempts to
contact them. Therefore, this left a total of 19 active data points
and 19 placebo data points at three months. At three months, these
patients had received, on average, 6 applications of the PCS-01
formulation to their lesions.
All viable data was then analyzed, first using a Shapiro-Wilk
evaluation for continuous summary descriptives. The mean number of
benign epidermal proliferations remaining at Day 0 at actively
treated sites was 29 (SE 5.5404), while the mean number of benign
epidermal proliferations remaining for placebo treated sites at Day
0 was 23 (SE 4.4663). The mean number of benign epidermal
proliferations remaining at Day 90 at actively treated sites was
two (SE 0.5299), while the mean number of benign epidermal
proliferations remaining for placebo treated sites at Day 90 was 23
(SE 4.4642). This was statistically significant in a paired samples
t-test of active versus placebo at Day 90 (p-value<0.0001).
Again, these analyses were done using paired sample, two tailed
t-tests This data is summarized in tabular form below:
TABLE-US-00001 Day 0 - Treated Patients n 20 (cases excluded: 3 due
to missing value) Mean 28.650 95% Cl 17.054 to 40.246 Variance
613.9237 SD 24.775 SE 5.5404 CV 86% Median 23.000 95.9% Cl 7.000 to
36.000 Range 81 IQR 42.25 Percentile 2.5.sup.th -- 25.sup.th 6.500
50.sup.th 23.000 75.sup.th 48.750 97.5.sup.th --
TABLE-US-00002 Day 0 - Untreated Patients n 20 (cases excluded: 3
due to missing value) Mean 23.373 95% Cl 14.025 to 32.721 Variance
398.9538 SD 19.9738 SE 4.4663 CV 85% Median 25.000 95.9% Cl 7.000
to 31.000 Range 65 IQR 29.75 Percentile 2.5.sup.th -- 25.sup.th
6.500 50.sup.th 25.000 75.sup.th 36.250 97.5.sup.th --
TABLE-US-00003 Day 90 - Treated Patients n 20 (cases excluded: 3
due to missing value) Mean 1.396 95% Cl 0.287 to 2.5056 Variance
5.6165 SD 2.3699 SE 0.5299 CV 170% Median 0.000 95.9% Cl 0.000 to
1.923 Range 8 IQR 2.730769231 Percentile 2.5.sup.th -- 25.sup.th
0.000 50.sup.th 0.000 75.sup.th 2.731 97.5.sup.th --
TABLE-US-00004 Day 90 - Untreated Patients n 20 (cases excluded: 3
due to missing value) Mean 23.319 95% Cl 13.975 to 32.663 Variance
398.5888 SD 19.9647 SE 4.4642 CV 86% Median 24.500 95.9% Cl 7.000
to 31.000 Range 65 IQR 29.75 Percentile 2.5.sup.th -- 25.sup.th
6.500 50.sup.th 24.500 75.sup.th 36.250 97.5.sup.th --
No adverse events directly attributable to the formulation of the
present invention were found during this phase of the study. When
the formulation was applied, the patients noted a transient, less
than 10 minute burning following application of formulation of the
present invention. On a discomfort scale, with 1 being no
discomfort and 10 being maximal discomfort, the patients average
rating was a 2.5.
The following examples are included to demonstrate preferred
embodiments of the invention. It should be appreciated by those of
skill in the art that the techniques disclosed in the examples
which follow represent techniques discovered by the inventors to
function well in the practice of the invention, and thus can be
considered to constitute preferred modes for its practice. However,
those of skill in the art should, in light of the present
disclosure, appreciate that many changes can be made in the
specific embodiments which are disclosed and still obtain a like or
similar result without departing from the spirit and scope of the
invention.
EXAMPLE 1
Acanthotic Seborrheic Keratosis Removal
The following is a general procedure or method for application of
the selected agents and compositions for the removal of acanthotic
seborrheic keratoses:
a. complete medical history form and discuss procedure with the
seborrheic keratoses afflicted individual;
b. conduct full body examination to locate any various seborrheic
keratoses overlooked by afflicted person and detect any
newly-forming seborrheic keratoses;
c. photograph seborrheic keratoses, preferably with 1.times.,
30.times. and 50.times. magnification;
d. cleanse seborrheic keratoses with pHaze 1 Facial Wash.TM.
(Physician's Choice of Arizona) cleansing composition;
e. apply neutralizer composition to the skin surrounding seborrheic
keratosis;
f. apply 50 percent hydrogen peroxide acanthotic seborrheic
keratosis composition with appropriate application instrument
(e.g., a brush);
g. accelerate drying with miniature heated forced air dryer;
h. watch for appearance of blanching and bubbling reaction;
i. make second application of acanthotic seborrheic keratosis
composition if necessary;
j. photograph seborrheic keratoses, preferably with 1.times.,
30.times. and 50.times. magnification;
k. supply seborrheic keratosis afflicted person with pHaze 17
ReBalance.TM. cream for application eight hours post seborrheic
keratosis treatment;
l. inform carrier that seborrheic keratoses should spontaneously
detach 3 to 6 days after procedure;
m. re-apply pHaze 17 ReBalance.TM. cream to seborrheic keratosis
skin attachment site after seborrheic keratosis detaches;
n. check at weekly intervals to ensure re-growth does not
occur.
EXAMPLE 2
Hyperkeratotic Seborrheic Keratosis Removal
The following is a general method for the alleviation of the
dome-shaped papules known as hyperkeratotic seborrheic keratoses,
which usually involve the trunk and lower extremities:
a. complete medical history form and discuss procedure with the
hyperkeratotic seborrheic keratosis afflicted individual;
b. conduct full body examination to locate all hyperkeratotic
seborrheic keratoses;
c. photograph hyperkeratotic seborrheic keratoses, preferably with
1.times., 30.times. and 50.times. magnification;
d. cleanse hyperkeratotic seborrheic keratoses with pHaze 1 Facial
Wash.TM. cleansing composition;
e. apply pHaze 17 ReBalance.TM. cream to skin surrounding
hyperkeratotic seborrheic keratoses;
f. apply hyperkeratotic seborrheic keratosis induction formulation
containing 45 percent hydrogen peroxide;
g. accelerate evaporation with heated forced air dryer;
h. watch for appearance of blanching and bubbling reaction;
i. make second application of hyperkeratotic seborrheic keratoses
apoptotic induction formulation, if necessary, to achieve complete
penetration;
j. photograph hyperkeratotic seborrheic keratoses, preferably with
1.times., 30.times. and 50.times. magnification;
k. supply hyperkeratotic seborrheic keratosis afflicted individual
with pHaze 17 ReBalance.TM. cream for application eight hours post
apoptotic induction treatment;
l. inform hyperkeratotic seborrheic keratosis afflicted individual
that apoptotic crust should form after one day and crust should
separate after approximately 3 days;
m. re-apply pHaze 17 ReBalance.TM. cream to hyperkeratotic
seborrheic keratoses lesions after crust separation;
n. re-treat hyperkeratotic seborrheic keratoses two days after
crust separation until satisfactory elimination of lesions is
achieved.
EXAMPLE 3
Dermatolipoma Seborrheic Keratosis Removal
Type III fat filled acrochordon seborrheic keratosis variants known
as dermatolipoma acrochordons require a modified procedure and a
specialized depedunculation formulation application such as the
following:
a. complete medical history form and discuss procedure with the
dermatolipoma acrochordon afflicted individual;
b. conduct full body examination to locate all dermatolipoma
seborrheic keratoses;
c. perform photographic documentation at specified
magnifications;
d. dehydrate dermatolipoma surface with heated air blower;
e. apply dermatolipoma 35 percent hydrogen peroxide depedunculation
formulation;
f. monitor reaction and reapply to achieve thorough lesion
blanching;
g. re-treat dermatolipomas that do not depedunculate 5 days post
initial treatment.
EXAMPLE 4
Verrucous Seborrheic Keratosis Treatment
The following general procedure should be utilized for the
treatment of verrucous seborrheic keratoses with diffuse
parakeratosis and absence of the granular layer:
a. complete medical history form and discuss procedure with the
verrucous seborrheic keratosis carrier;
b. conduct photographic documentation;
c. layer two applications of the 38 percent hydrogen peroxide
formulation to the verrucous seborrheic keratoses;
d. treat the verrucous seborrheic keratoses with the A&C
Synergy Serum.TM. (Physician's Choice of Arizona) one day post
treatment;
e. retreat any unresolved verrucous seborrheic keratoses at 5 day
intervals.
EXAMPLE 5
Seborrheic Keratosis Prevention Treatment
The following seborrheic keratosis prevention treatment should be
adjusted depending on individual skin sensitivity and propensity
for seborrheic keratosis proliferation:
a. fill a bath tub with moderately warm water;
b. add the container of the 35 percent hydrogen peroxide solution
to the bath water;
c. soak in the tub with the seborrheic keratosis prevention
solution for at least fifteen minutes;
d. repeat the treatment at weekly intervals;
e. treat any existing seborrheic keratoses with the concentrated
seborrheic keratosis solution.
EXAMPLE 6
Clear Cell Acanthoma Treatment
a. complete medical history form and discuss clear cell acanthoma
treatment with the subject;
b. conduct full body examination to locate all lesions to be
treated and categorize lesion types;
c. perform photographic documentation at various
magnifications;
d. pHaze 17 ReBalance.TM. cream to surround clear cell
acanthoma;
e. apply 45 percent hydrogen peroxide solution to achieve
saturation of each clear cell acanthoma;
f. check for resolution of lesions 5 days post treatment.
Exemplary compositions in accordance with the present invention
include:
EXAMPLE A
Hydrogen peroxide (at least 23%)
Witch hazel
Aloe vera
Lactic acid, about 2 to 10%, preferably about 5%
Citric acid, about 2 to 10%, preferably about 5%
Water
EXAMPLE B
Hydrogen peroxide (at least 23%)
Aminoguanidine 0.1 to 5%, preferably about 1%
Lactic acid, about 2 to 10%, preferably about 5%
Citric acid, about 2 to 10%, preferably about 5%
Water
EXAMPLE C
Hydrogen peroxide (at least 23%)
L-ascorbic acid, about 5% to 10%
L-arbutin
Kojic acid
Hydroqinone
Lactic acid
Licorice root extract
Retinol
Water
EXAMPLE D
Hydrogen peroxide (at least 23%)
L-ascorbic acid, about 5% to 10%
Methyl sulfonyl methane (MSM)
Sodium hyaluronate
Water
EXAMPLE E
Hydrogen peroxide (at least 23%)
Azelaic acid
Glucosamine
Niacinamide
Witch hazel
Water
Since specific individual seborrheic keratosis type and conditions
may warrant changes and modifications of the present seborrheic
keratosis removal and prevention invention and can readily be made
by those skilled in the art of seborrheic keratosis removal and
prevention without departing from the basic concept of the present
invention, the present invention for seborrheic keratosis removal
and prevention shall not be limited except by the scope of the
appended claims.
All of the treatments and/or methods disclosed and claimed herein
can be made and executed without undue experimentation in light of
the present disclosure. While the treatments and methods of this
invention have been described in terms of preferred embodiments, it
will be apparent to those of skill in the art that variations may
be applied to the treatments and/or methods and in the steps or in
the sequence of steps of the method described herein without
departing from the concept, spirit and scope of the invention. More
specifically, it will be apparent that certain seborrheic keratosis
removal and prevention agents which are both chemically and
physiologically related may be substituted for the agents described
herein while the same or similar results would be achieved. All
such similar substitutes and modifications apparent to those
skilled in the art of seborrheic removal and prevention are deemed
to be within the spirit, scope and concept of the invention as
defined by the appended claims.
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The following references, to the extent that they provide exemplary
procedural or other details supplementary to those set forth
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U.S. Pat. No. 6,036,684, March, 2000 to Tankovich
U.S. Pat. No. 6,171,593, January, 2001 to Williams
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